Fissure-forming drill 2.2 mm diameter (M4X0.5) - Delynov - Helmut Zepf (26.120.322TI) - Delynov

What is the Helmut Zepf 2.2 mm fissure former?

The Helmut Zepf fissure former is a manual dental instrument designed for precision work on occlusal surfaces. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device features a diameter of 2.2 mm with a specified M4X0.5 thread. As a groove modeling instrument, it allows for the sculpting of restorative materials with high technical rigor. This device belongs to Class I of medical devices, guaranteeing its compliance with basic regulatory standards for manual instrumentation in dental practices.

What are the clinical indications for the dental fissure former?

This dental fissure former is primarily indicated for occlusal modeling during direct or indirect restoration phases. Its role is essential for recreating the functional anatomy of the tooth, particularly by defining grooves and pits. In conservative surgery and restorative dentistry, the instrument allows for guiding the filling material to ensure optimal occlusion. Its use is strictly reserved for qualified healthcare professionals operating within standard dental care protocols requiring precise morphological finishing.

What are the technical characteristics of this instrument?

The fissure former (reference 26.120.322TI) is distinguished by a working diameter of 2.2 mm. The technical specification mentions a reference code M4X0.5, which defines its mounting interface or thread structure. Designed by Helmut Zepf, the instrument is delivered non-sterile and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before the first use as well as between each patient. Its medical stainless steel design ensures the necessary resistance to thermal and chemical reprocessing cycles in an autoclave.

What are the contraindications for the use of this instrument?

The main contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity or intolerance to metals. Since the instrument is composed of medical stainless steel, contact with an allergic patient may trigger a hypersensitivity reaction. If such a reaction occurs during the procedure, use must be immediately discontinued and appropriate medical measures must be taken. Additionally, it is formally advised against using the instrument if it shows visible damage, such as cracks, breaks, or defects on the cutting edges.

What are the maintenance and reprocessing precautions?

As it is a non-resorbable and reusable instrument, a strict reprocessing protocol is mandatory. Before each use, the practitioner must check for the absence of wear or structural damage. Due to its design and the materials used, there is no defined maximum limit of treatment cycles, but pre-operative visual examination remains the rule. Cleaning must be meticulous to remove all residues before sterilization. The use of damaged or worn products is prohibited to guarantee patient safety and the effectiveness of the clinical procedure.

Who is the manufacturer and what standards are respected?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Germany. This fissure former is classified as a Class I medical device according to current regulations. The manufacturer requires that all instruments be cleaned, disinfected, and sterilized before any initial and subsequent use. Compatibility with other products from the Helmut Zepf system must also be verified beforehand by the healthcare professional. Compliance with these protocols ensures the device's conformity with safety requirements for use in a clinical setting.

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